Gut microbiome links to outcomes in intracranial arterial stenosis

Correlation Study Between Gut Microbiota and Prognosis in Patients With Intracranial Arterial Stenosis（GROW-ICAS）

This project will see if gut microbiome, metabolite, and gene-expression patterns relate to recovery, artery plaque features, and non-motor problems (thinking, mood, and fatigue) in people aged 30-80 with intracranial arterial stenosis.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07085299 on ClinicalTrials.gov

What this trial studies

GROW-ICAS is a prospective observational cohort that enrolls adults aged 30-80 with intracranial arterial stenosis confirmed by CTA, MRA, or DSA. The study collects stool for gut microbiota analysis and blood for metabolomic and transcriptomic profiling alongside standardized imaging and clinical assessments. Investigators will correlate microbial and molecular profiles with functional outcomes, intracranial plaque imaging characteristics, and post-stroke non-motor dysfunctions such as cognitive impairment, depression, anxiety, and fatigue. Key exclusions (non-atherosclerotic causes, recent interventions, active hemorrhage, major comorbidities, or inability to follow up) are applied to maintain a homogeneous cohort.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30-80 with intracranial arterial stenosis confirmed by CTA/MRA/DSA, who have lived locally for at least six months and can provide informed consent.

Not a fit: Patients with non-atherosclerotic stenosis, tandem extracranial stenosis, recent or planned revascularization, recent intracranial hemorrhage, severe neurological disability or dementia, chronic inflammatory disease, active bleeding, or pregnancy are unlikely to benefit from this observational project.

Why it matters

Potential benefit: If successful, the project could identify gut-derived biomarkers that help predict recovery, plaque behavior, or risk of cognitive and mood problems, informing personalized monitoring or future treatments.

How similar studies have performed: Previous studies have suggested associations between gut microbiota and stroke or vascular disease outcomes, but combining microbiome, metabolomic, and transcriptomic profiling specifically in intracranial arterial stenosis is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age 30-80 years.
2. Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
3. Local residency ≥6 consecutive months.
4. Signed informed consent.

Exclusion Criteria:

1. Tandem extracranial stenosis (≥50%) proximal to the target intracranial stenotic vessel.
2. Non-atherosclerotic intracranial stenosis.
3. Extracranial/intracranial endovascular treatment within 30 days pre-enrollment or planned intervention within 6 months.
4. Intracranial hemorrhage within 90 days pre-enrollment.
5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
6. Cardioembolic embolism.
7. Active bleeding/hemorrhagic diathesis.
8. Major surgery within 30 days pre-enrollment or planned within 6 months post-enrollment.
9. Severe neurological deficits impairing independent living or dementia/psychiatric disorders hindering follow-up.
10. Pregnancy/lactation/planned pregnancy.
11. Chronic inflammatory/autoimmune diseases.
12. Uncontrolled hypertension or diabetes.
13. Severe cardiac/hepatic/renal dysfunction, hematologic disorders, malignancy, or life expectancy \<1 year.
14. MRI contraindications.
15. History of depression/anxiety/cognitive impairment requiring therapy.
16. Antibiotic/probiotic/glucocorticoid/immunosuppressant use within 1 month pre-enrollment.
17. Current/planned participation in other trials.
18. Inability to cooperate due to psychiatric/emotional disorders.
19. Other investigator-deemed ineligibility.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Junshan Zhou

Conditions Intracranial Artery Stenosis; intracranial artery stenosis; Gut Microbiota